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TPLC
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show TPLC since
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Device
mixer, breathing gases, anesthesia inhalation
Product Code
BZR
Regulation Number
868.5330
Device Class
2
Premarket Reviews
Manufacturer
Decision
ATOM MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
BALDUS SEDATION GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
2
CARDINAL HEALTH 207, INC.
SUBSTANTIALLY EQUIVALENT
1
DEHAS MEDICAL SYSTEMS GMBH
SUBSTANTIALLY EQUIVALENT
1
GENTEC (SHANGHAI) CORPORATION
SUBSTANTIALLY EQUIVALENT
1
LINDE HEALTHCARE AB
SUBSTANTIALLY EQUIVALENT
1
MAXTEC, INC.
SUBSTANTIALLY EQUIVALENT
1
MAXTEC, LLC
SUBSTANTIALLY EQUIVALENT
2
O-TWO MEDICAL TECHNOLOGIES INC.
SUBSTANTIALLY EQUIVALENT
1
O-TWO MEDICAL TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
PARKER HANNIFIN
SUBSTANTIALLY EQUIVALENT
1
PARKER HANNIFIN CORPORATION
SUBSTANTIALLY EQUIVALENT
1
PRECISION MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
11
11
2015
39
39
2016
30
30
2017
22
22
2018
24
24
2019
26
26
2020
15
15
2021
33
33
2022
15
15
2023
19
19
2024
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
39
39
Inaccurate Delivery
32
32
Device Operates Differently Than Expected
29
29
No Audible Alarm
21
21
Device Alarm System
17
17
Leak/Splash
17
17
Output Problem
8
8
Infusion or Flow Problem
7
7
Out-Of-Box Failure
6
6
Gas Output Problem
5
5
Defective Device
5
5
Therapeutic or Diagnostic Output Failure
5
5
Fire
5
5
No Flow
4
4
No Apparent Adverse Event
4
4
Calibration Problem
4
4
Material Integrity Problem
4
4
Failure to Calibrate
4
4
Improper Device Output
4
4
Loose or Intermittent Connection
3
3
Protective Measures Problem
3
3
Medical Gas Supply Problem
3
3
False Alarm
3
3
Gas/Air Leak
3
3
Pressure Problem
2
2
Output above Specifications
2
2
High Readings
2
2
Appropriate Term/Code Not Available
2
2
Insufficient Information
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Positioning Problem
2
2
Failure to Deliver
2
2
Contamination
2
2
Improper Flow or Infusion
2
2
Excess Flow or Over-Infusion
2
2
Delayed Alarm
2
2
No Display/Image
1
1
Volume Accuracy Problem
1
1
Naturally Worn
1
1
Break
1
1
Melted
1
1
No Device Output
1
1
Improper or Incorrect Procedure or Method
1
1
Device Displays Incorrect Message
1
1
Display or Visual Feedback Problem
1
1
Incorrect Measurement
1
1
Free or Unrestricted Flow
1
1
Programming Issue
1
1
Device Sensing Problem
1
1
Insufficient Flow or Under Infusion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
99
99
No Clinical Signs, Symptoms or Conditions
67
67
Low Oxygen Saturation
25
25
No Known Impact Or Consequence To Patient
20
20
No Consequences Or Impact To Patient
11
11
Insufficient Information
8
8
No Information
7
7
Superficial (First Degree) Burn
2
2
Respiratory Distress
2
2
Complaint, Ill-Defined
1
1
High Oxygen Saturation
1
1
Death
1
1
No Code Available
1
1
Respiratory Arrest
1
1
Abnormal Blood Gases
1
1
Abdominal Distention
1
1
Overdose
1
1
Retinal Injury
1
1
Hypoxia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CAREstream Medical LLC
II
Aug-22-2018
2
O-Two Medical Technologies, Inc.
II
Aug-22-2018
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